Multi Center, Prospective, Registry Trial of Versi Retriever Mechanical Thrombecomy for Acute Ischemic Stroke in Japan
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Good clinical outcome
Study Overview
Brief Summary
This is Versi Retriever mechanical thrombectomy device approving study in Japan. Multi center, single arm, prospective registry trial. Physicians control trial, conducted my N Sakai, Kobe City Medical Center General Hospital.
Detailed Description
This is Versi Retriever mechanical thrombectomy device approving study in Japan. Multi center, single arm, prospective registry trial. Physicians control trial, conducted my N Sakai, Kobe City Medical Center General Hospital.
60 cases will be enrolled and 90 days follow up need. Primary endpoint is favorable clinical outcome, mRS 0-2. Secondary endpoint are mortality in 90days, immediate successful recanalization, TICI 2b-3, symptomatic intracranial hemorrhage, and any adverse event related to device and or procedure.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •acute onset neurological sympto m related to occluded vessel
- •within 8 hours from onset to tre atment or within 24 hours from onset to treatment with imaging diagnosis
- •contra-indication or failed to int ravenous rt-PA
- •accessible occlusion at ICA, MC A, VA, BA, PCA
- •5-30 of NIHSS
- •0-2 of mRS before onset
- •obtain documented informed co ntent
Exclusion Criteria
- •following condition; arterial diss ection, engird, inaccessible turtuousity, difficult access by 50% or m ore stenosis, acute intracranial hemorrhage, space occuping lesion or brain tumor, major early ischemic change in brain
- •occlude 2 major vessel territory
- •allege for contrast media,
- •abnormal PTT/APTT within 4 h ours intravenous heparin
- •hemorrhagic tendency or 3 or more INR with Warfarin administration
- •30000cc or less of Platelet
- •50mg/dL or less of blood sugar
- •uncontrolled blood pressure, 185mmHg or more at systolic, 110m mHg or more at diastolic
- •90days or less life expancy
- •pregnant or lactating
- •join another trial of medicine or medical device
- •ineligible for trial
Arms & Interventions
Trial arm
Mechanical thrombectomy using Versi Retriever
Intervention: Versi Retriever thrombectomy (Device)
Outcomes
Primary Outcomes
Good clinical outcome
Time Frame: 90days after procedure
modified Rankin Score is 0-2
Secondary Outcomes
- Successful recanalization(at end of procedure)
- Good clinical outcome 2(90days after procedure)
- Symptomatic and asymptomatic intracranial hemorrhage(at 24 hours after procedure)
- sever advers event(90days after procedure)
- Successful recanalization(at 3 passes of device in the procedure)
Investigators
Nobuyuki Sakai
Director, Neurosurgery
Kobe City General Hospital